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FDA 510(k)

Distal Centralizers

K-Number: K193546 · 2020-09-25

ApplicantBiomet, Inc.
Decision Date2020-09-25
Product CodeJDG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Distal Centralizers is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2020-09-25 under 510(k) number K193546. The device is classified under product code JDG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Distal Centralizers?

Distal Centralizers is a medical device that received FDA 510(k) clearance on 2020-09-25. The listed applicant is Biomet, Inc.. The 510(k) number is K193546.

When did Distal Centralizers receive FDA 510(k) clearance?

Distal Centralizers received FDA 510(k) clearance on 2020-09-25, under 510(k) number K193546.

Who is the listed applicant for Distal Centralizers?

The FDA 510(k) record lists Biomet, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Distal Centralizers?

The FDA product code for Distal Centralizers is JDG.

Other records listing Biomet, Inc. as applicant

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Related Devices (Code: JDG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212431Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveBiomet, Inc.K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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